Effects of two different anesthesia-analgesia methods on incidence of postoperative delirium in elderly patients undergoing major thoracic and abdominal surgery: study rationale and protocol for a multicenter randomized controlled trial

Ya-Wei Li, Hui-Juan Li, Huai-Jin Li, Yi Feng, Yao Yu, Xiang-Yang Guo, Yan Li, Bin-Jiang Zhao, Xiao-Yun Hu, Ming-Zhang Zuo, Hong-Ye Zhang, Mei-Rong Wang, Ping Ji, Xiao-Yan Yan, Yang-Feng Wu, Dong-Xin Wang, Ya-Wei Li, Hui-Juan Li, Huai-Jin Li, Yi Feng, Yao Yu, Xiang-Yang Guo, Yan Li, Bin-Jiang Zhao, Xiao-Yun Hu, Ming-Zhang Zuo, Hong-Ye Zhang, Mei-Rong Wang, Ping Ji, Xiao-Yan Yan, Yang-Feng Wu, Dong-Xin Wang

Abstract

Background: Delirium is a common complication in elderly patients after surgery and associated with increased morbidity and mortality. Studies suggest that deep anesthesia and intense pain are important precipitating factors of postoperative delirium. Neuraxial block is frequently used in combination with general anesthesia for patients undergoing major thoracic and abdominal surgery. Compared with general anesthesia alone and postoperative intravenous analgesia, combined epidural-general anesthesia and postoperative epidural analgesia decreases the requirement of general anesthetics during surgery and provided better pain relief after surgery. However, whether combined epidural-general anesthesia plus epidural analgesia is superior to general anesthesia plus intravenous analgesia in decreasing the incidence of postoperative delirium remains unknown.

Methods/design: This is a multicenter, open-label, randomized, parallel-controlled clinical trial. One thousand eight hundred elderly patients (age range 60-90 years) who are scheduled to undergo major thoracic or abdominal surgery are randomized to receive either general anesthesia plus postoperative intravenous analgesia or combined epidural-general anesthesia plus postoperative epidural analgesia. The primary outcome is the 7-day incidence of postoperative delirium. Secondary outcomes include the duration of postoperative delirium, the intensity of pain during the first three days after surgery, the 30-day incidences of postoperative non-delirium complications, the length of stay in hospital after surgery and 30-day all-cause mortality.

Discussion: Results of the present study will provide information to guide clinical practice in choosing appropriate anesthesia-analgesia method for elderly patients undergoing major thoracic and abdominal surgery.

Trial registration: The study is registered on ClinicalTrials.gov NCT01661907 and Chinese Clinical Trial Registry ChiCTR-TRC-12002371 .

Figures

Fig. 1
Fig. 1
Design of the study

References

    1. American Psychiatric Association . Diagnostic and Statistical Manual of Mental Disorders. 4. Washington: American Psychiatric Association; 1994.
    1. Dyer CB, Ashton CM, Teasdale TA. Postoperative delirium-A review of 80 primary data-collection studies. Arch Intern Med. 1995;155:461–465. doi: 10.1001/archinte.1995.00430050035004.
    1. Girard TD, Pandharipande PP, Ely EW. Delirium in the intensive care unit. Crit Care. 2008;12(3):S3. doi: 10.1186/cc6149.
    1. Mu DL, Wang DX, Li LH, Shan GJ, Li J, Yu QJ, et al. High serum cortisol level is associated with increased risk of delirium after coronary artery bypass graft surgery: a prospective cohort study. Crit Care. 2010;14:R238. doi: 10.1186/cc9393.
    1. Shi CM, Wang DX, Chen KS, Gu XE. Incidence and risk factors of delirium in critically ill patients after non-cardiac surgery. Chin Med J (Engl) 2010;123:993–999.
    1. Roberts B, Rickard CM, Rajbhandari D, Turner G, Clarke J, Hill D, et al. Multicentre study of delirium in ICU patients using a simple screening tool. Aust Crit Care. 2005;18:6. doi: 10.1016/S1036-7314(05)80019-0.
    1. Balas MC, Happ MB, Yang W, Chelluri L, Richmond T. Outcomes associated with delirium in older patients in surgical ICUs. Chest. 2009;135:18–25. doi: 10.1378/chest.08-1456.
    1. Ely EW, Gautam S, Margolin R, Francis J, May L, Speroff T, et al. The impact of delirium in the intensive care unit on hospital length of stay. Intensive Care Med. 2001;27:1892–1900. doi: 10.1007/s00134-001-1132-2.
    1. Ansaloni L, Catena F, Chattat R, Fortuna D, Franceschi C, Mascitti P, et al. Risk factors and incidence of postoperative delirium in elderly patients after elective and emergency surgery. Br J Surg. 2010;97:273–280. doi: 10.1002/bjs.6843.
    1. Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE, Jr, et al. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004;291:1753–1762. doi: 10.1001/jama.291.14.1753.
    1. Franco K, Litaker D, Locala J, Bronson D. The cost of delirium in the surgical patient. Psychosomatics. 2001;42:68–73. doi: 10.1176/appi.psy.42.1.68.
    1. Milbrandt EB, Deppen S, Harrison PL, Shintani AK, Speroff T, Stiles RA, et al. Costs associated with delirium in mechanically ventilated patients. Crit Care Med. 2004;32:955–962. doi: 10.1097/01.CCM.0000119429.16055.92.
    1. Pisani MA, Kong SY, Kasl SV, Murphy TE, Araujo KL, Van Ness PH. Days of delirium are associated with 1-year mortality in an older intensive care unit population. Am J Respir Crit Care Med. 2009;180:1092–1097. doi: 10.1164/rccm.200904-0537OC.
    1. Bickel H, Gradinger R, Kochs E, Förstl H. High risk of cognitive and functional decline after postoperative delirium: A three-year prospective study. Dement Geriatr Cogn Disord. 2008;26:26–31. doi: 10.1159/000140804.
    1. Van Rompaey B, Schuurmans MJ, Shortridge-Baggett LM, Truijen S, Elseviers M, Bossaert L. Long term outcome after delirium in the intensive care unit. J Clin Nurs. 2009;18:3349–3357. doi: 10.1111/j.1365-2702.2009.02933.x.
    1. Moyce Z, Rodseth RN, Biccard BM. The efficacy of perioperative interventions to decrease postoperative delirium in non-cardiac surgery: a systematic review and meta-analysis. Anaesthesia. 2014;69:259–269. doi: 10.1111/anae.12539.
    1. American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults American Geriatrics Society abstracted clinical practice guideline for postoperative delirium in older adults. J Am Geriatr Soc. 2015;63:142–150. doi: 10.1111/jgs.13281.
    1. Steiner LA. Postoperative delirium. In: Part 1: pathophysiology and risk factors. Eur J Anaesthesiol. 2011;28:628–636. doi: 10.1097/EJA.0b013e328349b7f5.
    1. Fong HK, Sands LP, Leung JM. The role of postoperative analgesia in delirium and cognitive decline in elderly patients: a systematic review. Anesth Analg. 2006;102:1255–1266. doi: 10.1213/01.ane.0000198602.29716.53.
    1. Santarpino G, Fasol R, Sirch J, Ackermann B, Pfeiffer S, Fischlein T. Impact of bispectral index monitoring on postoperative delirium in patients undergoing aortic surgery. HSR Proc Intensive Care Cardiovasc Anesth. 2011;3:47–58.
    1. Jildenstål PK, Hallén JL, Rawal N, Gupta A, Berggren L. Effect of auditory evoked potential-guided anaesthesia on consumption of anaesthetics and early postoperative cognitive dysfunction: a randomised controlled trial. Eur J Anaesthesiol. 2011;28:213–219. doi: 10.1097/EJA.0b013e328340dbb9.
    1. Chan MT, Cheng BC, Lee TM, Gin T, CODA Trial Group BIS-guided anesthesia decreases postoperative delirium and cognitive decline. J Neurosurg Anesthesiol. 2013;25:33–42. doi: 10.1097/ANA.0b013e3182712fba.
    1. Radtke FM, Franck M, Lendner J, Krüger S, Wernecke KD, Spies CD. Monitoring depth of anaesthesia in a randomized trial decreases the rate of postoperative delirium but not postoperative cognitive dysfunction. Br J Anaesth. 2013;110(Suppl 1):i98–i105. doi: 10.1093/bja/aet055.
    1. Leung JM, Sands LP, Paul S, Joseph T, Kinjo S, Tsai T. Does postoperative delirium limit the use of patient-controlled analgesia in older surgical patients? Anesthesiology. 2009;111:625–631. doi: 10.1097/ALN.0b013e3181acf7e6.
    1. Leung JM, Sands LP, Lim E, Tsai TL, Kinjo S. Does preoperative risk for delirium moderate the effects of postoperative pain and opiate use on postoperative delirium? Am J Geriatr Psychiatry. 2013;21:946–956. doi: 10.1016/j.jagp.2013.01.069.
    1. Leung JM, Sands LP, Rico M, Petersen KL, Rowbotham MC, Dahl JB, et al. Pilot clinical trial of gabapentin to decrease postoperative delirium in older patients. Neurology. 2006;67:1251–1253. doi: 10.1212/01.wnl.0000233831.87781.a9.
    1. Krenk L, Rasmussen LS, Hansen TB, Bogø S, Søballe K, Kehlet H. Delirium after fast-track hip and knee arthroplasty. Br J Anaesth. 2012;108:607–611. doi: 10.1093/bja/aer493.
    1. Rodgers A, Walker N, Schug S, McKee A, Kehlet H, van Zundert A, et al. Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. BMJ. 2000;321:1493. doi: 10.1136/bmj.321.7275.1493.
    1. Park WY, Thompson JS, Lee KK. Effect of epidural anesthesia and analgesia on perioperative outcome: a randomized, controlled Veterans Affairs cooperative study. Ann Surg. 2001;234:560–569. doi: 10.1097/00000658-200110000-00015.
    1. Rigg JR, Jamrozik K, Myles PS, Silbert BS, Peyton PJ, Parsons RW, et al. Epidural anaesthesia and analgesia and outcome of major surgery: a randomised trial. Lancet. 2002;359:1276–1282. doi: 10.1016/S0140-6736(02)08266-1.
    1. Ballantyne JC, Kupelnick B, McPeek B, Lau J. Does the evidence support the use of spinal and epidural anesthesia for surgery? J Clin Anesth. 2005;17:382–391. doi: 10.1016/j.jclinane.2004.10.005.
    1. Behera BK, Puri GD, Ghai B. Patient-controlled epidural analgesia with fentanyl and bupivacaine provides better analgesia than intravenous morphine patient-controlled analgesia for early thoracotomy pain. J Postgrad Med. 2008;54:86–90. doi: 10.4103/0022-3859.40772.
    1. Guay J, Choi PT, Suresh S, Albert N, Kopp S, Pace NL. Neuraxial anesthesia for the prevention of postoperative mortality and major morbidity: an overview of Cochrane systematic reviews. Anesth Analg. 2014;119:716–725. doi: 10.1213/ANE.0000000000000339.
    1. Mason SE, Noel-Storr A, Ritchie CW. The impact of general and regional anesthesia on the incidence of post-operative cognitive dysfunction and postoperative delirium: a systematic review with meta-analysis. J Alzheimers Dis. 2010;22(Suppl 3):67–79.
    1. Zhang H, Lu Y, Liu M, Zou Z, Wang L, Xu FY, et al. Strategies for prevention of postoperative delirium: a systematic review and meta-analysis of randomized trials. Crit Care. 2013;17:R47. doi: 10.1186/cc12566.
    1. Hodgson PS, Liu SS. Epidural lidocaine decreases sevoflurane requirement for adequate depth of anesthesia as measured by the Bispectral Index monitor. Anesthesiology. 2001;94:799–803. doi: 10.1097/00000542-200105000-00018.
    1. Reinoso-Barbero F, Martínez-García E, Hernández-Gancedo MC, Simon AM. The effect of epidural bupivacaine on maintenance requirements of sevoflurane evaluated by bispectral index in children. Eur J Anaesthesiol. 2006;23:460–464. doi: 10.1017/S0265021506000330.
    1. Ezhevskaya AA, Mlyavykh SG, Anderson DG. Effects of continuous epidural anesthesia and postoperative epidural analgesia on pain management and stress response in patients undergoing major spinal surgery. Spine (Phila Pa 1976) 2013;38:1324–1330. doi: 10.1097/BRS.0b013e318290ff26.
    1. Khajavi MR, Asadian MA, Imani F, Etezadi F, Moharari RS, Amirjamshidi A. General anesthesia versus combined epidural/general anesthesia for elective lumbar spine disc surgery: A randomized clinical trial comparing the impact of the two methods upon the outcome variables. Surg Neurol Int. 2013;4:105. doi: 10.4103/2152-7806.116683.
    1. Bryson GL, Wyand A. Evidence-based clinical update: general anesthesia and the risk of delirium and postoperative cognitive dysfunction. Can J Anaesth. 2006;53:669–677. doi: 10.1007/BF03021625.
    1. Kamitani K, Higuchi A, Asahi T, Yoshida H. Postoperative delirium after general anesthesia vs. spinal anesthesia in geriatric patients. Masui. 2003;52:972–975.
    1. Papaioannou A, Fraidakis O, Michaloudis D, Balalis C, Askitopoulou H. The impact of the type of anaesthesia on cognitive status and delirium during the first postoperative days in elderly patients. Eur J Anaesthesiol. 2005;22:492–499. doi: 10.1017/S0265021505000840.
    1. Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R, et al. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) Crit Care Med. 2001;29:1370–1379. doi: 10.1097/00003246-200107000-00012.
    1. Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, et al. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU) JAMA. 2001;286:2703–2710. doi: 10.1001/jama.286.21.2703.
    1. Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O’Neal PV, Keane KA, et al. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002;166:1338–1344. doi: 10.1164/rccm.2107138.
    1. Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, et al. Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS) JAMA. 2003;289:2983–2991. doi: 10.1001/jama.289.22.2983.
    1. Peterson JF, Pun BT, Dittus RS, Thomason JW, Jackson JC, Shintani AK, et al. Delirium and its motoric subtypes: a study of 614 critically ill patients. J Am Geriatr Soc. 2006;54:479–484. doi: 10.1111/j.1532-5415.2005.00621.x.
    1. Pandharipande P, Cotton BA, Shintani A, Thompson J, Costabile S, Truman Pun B, et al. Motoric subtypes of delirium in mechanically ventilated surgical and trauma intensive care unit patients. Intensive Care Med. 2007;33:1726–1731. doi: 10.1007/s00134-007-0687-y.
    1. Collin C, Wade DT, Davies S, Horne V. The Barthel ADL Index: a reliability study. Int Disabil Stud. 1988;10:61–63. doi: 10.3109/09638288809164103.
    1. Richards SH, Peters TJ, Coast J, Gunnell DJ, Darlow MA, Pounsford J. Inter-rater reliability of the Barthel ADL index: how does a researcher compare to a nurse? Clin Rehabil. 2000;14:72–78. doi: 10.1191/026921500667059345.
    1. Katzman R, Zhang MY, Ouang-Ya-Qu, Wang ZY, Liu WT, Yu E, et al. A Chinese version of the Mini-Mental State Examination; impact of illiteracy in a Shanghai dementia survey. J Clin Epidemiol. 1988;41:971–978. doi: 10.1016/0895-4356(88)90034-0.
    1. Pangman VC, Sloan J, Guse L. An examination of psychometric properties of the mini-mental state examination and the standardized mini-mental state examination: implications for clinical practice. Appl Nurs Res. 2000;13:209–213. doi: 10.1053/apnr.2000.9231.
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–370. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002;52:69–77. doi: 10.1016/S0022-3999(01)00296-3.
    1. Cole MG. Delirium in elderly patients. Am J Geriatr Psychiatry. 2004;12:7–21. doi: 10.1097/00019442-200401000-00002.
    1. Inouye SK. Delirium in older persons. N Engl J Med. 2006;354:1157–1165. doi: 10.1056/NEJMra052321.
    1. Wang W, Li HL, Wang DX, Zhu X, Li SL, Yao GQ, et al. Haloperidol prophylaxis decreases delirium incidence in elderly patients after noncardiac surgery: a randomized controlled trial. Crit Care Med. 2012;40:731–739. doi: 10.1097/CCM.0b013e3182376e4f.
    1. Wijeysundera DN, Beattie WS, Austin PC, Hux JE, Laupacis A. Epidural anaesthesia and survival after intermediate-to-high risk non-cardiac surgery: a population-based cohort study. Lancet. 2008;372:562–569. doi: 10.1016/S0140-6736(08)61121-6.
    1. Nash DM, Mustafa RA, McArthur E, Wijeysundera DN, Paterson JM, Sharan S, et al. Combined general and neuraxial anesthesia versus general anesthesia: a population-based cohort study. Can J Anaesth. 2015;62:356–368. doi: 10.1007/s12630-015-0315-1.
    1. Jørgensen H, Wetterslev J, Møiniche S, Dahl JB. Epidural local anaesthetics versus opioid-based analgesic regimens on postoperative gastrointestinal paralysis, PONV and pain after abdominal surgery. Cochrane Database Syst Rev. 2000;4:CD001893.
    1. Pöpping DM, Elia N, Marret E, Remy C, Tramèr MR. Protective effects of epidural analgesia on pulmonary complications after abdominal and thoracic surgery: a meta-analysis. Arch Surg. 2008;143:990–999. doi: 10.1001/archsurg.143.10.990.
    1. Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: The Confusion Assessment Method: A new method for detecting delirium. Ann Intern Med. 1990;113:941–948. doi: 10.7326/0003-4819-113-12-941.
    1. Inouye SK. The Confusion Assessment Method (CAM): Training Manual and Coding Guide. New Haven: Yale University School of Medicine; 2003.
    1. Jl L, Vc L, Leung CM, Pan PC. Clinical utility and validation of two instruments (the Confusion Assessment Method Algorithm and the Chinese version of Nursing Delirium Screening Scale) to detect delirium in geriatric inpatients. Gen Hosp Psychiatry. 2008;30:171–176. doi: 10.1016/j.genhosppsych.2007.12.007.
    1. Wang C, Wu Y, Yue P, Ely EW, Huang J, Yang X, et al. Delirium assessment using Confusion Assessment Method for the Intensive Care Unit in Chinese critically ill patients. J Crit Care. 2013;28:223–229. doi: 10.1016/j.jcrc.2012.10.004.

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